BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 5077282 · Received September 15, 2015

    Report

    Report Number
    1823260-2015-04163
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE THYROTROPIN (TSH) RESULT FOR ONE PATIENT SAMPLE FROM A COBAS E602 ANALYZER. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND TESTED ON AN ANALYTICAL E MODULE, COBAS E411 AND A CENTAUR ANALYZER ON (B)(6) 2015. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. INFORMATION CONCERNING IF ANY RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT WAS NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED, BUT WAS NOT PROVIDED. FROM THE PROVIDED INFORMATION, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. FOR THYROID ASSAYS, THE PATIENT'S AGE, GENDER, AND OTHER CHARACTERISTICS SHOULD BE CONSIDERED WHEN EVALUATING THE RESULTS. THE RESULTS FOR THYROID ASSAYS CAN VARY DUE TO THE DIFFERENT SETUPS OF ALL ASSAYS, THE ANTIBODIES USED AND THE VARIANCES IN THE REFERENCE METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608443 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1